Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001186549
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
3/11/2015
Date last updated
17/02/2021
Date data sharing statement initially provided
24/09/2019
Date results provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised trial of division vs no division of the short gastric blood vessels during laparoscopic Nissen fundoplication for gastro-oesophageal reflux
Scientific title
Randomised trial of division vs no division of the short gastric blood vessels during laparoscopic Nissen fundoplication for gastro-oesophageal reflux
Secondary ID [1] 287766 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal reflux 2161 0
Condition category
Condition code
Oral and Gastrointestinal 2256 2256 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients undergoing a laparoscopic Nissen fundoplication were randomly assigned to undergo division or no division of the short gastric blood vessels. Following surgery they are followed clinically to assess reflux control and side effects
Intervention code [1] 1791 0
Treatment: Surgery
Comparator / control treatment
Nissen fundoplication with vs. without shorrt gastric blood vessel division
Control group
Active

Outcomes
Primary outcome [1] 3118 0
Dysphagia and other symptoms will be determined using a clinical questionairre
Timepoint [1] 3118 0
At 3 months, and then yearly for 20 years
Secondary outcome [1] 5235 0
nil
Timepoint [1] 5235 0
nil

Eligibility
Key inclusion criteria
Suitable for a laparoscopic Nissen fundoplication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not suitable for laproscopic Nissen fundoplication
severe oesophageal motility disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
120 Envelopes prepared by independent nurse (60 = treatment, 60=control), and shuffled extensively.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
patients and nurse undertaking follow-up blinded as to which operation was performed
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/1994
Date of last participant enrolment
Anticipated
Actual
1/01/1996
Date of last data collection
Anticipated
1/01/2020
Actual
1/01/2020
Sample size
Target
100
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 2417 0
Government body
Name [1] 2417 0
National Health and Medical Research Council
Country [1] 2417 0
Australia
Primary sponsor type
University
Name
Dept of Surgery, Flinders University
Address
Flinders University, South Australia
Country
Australia
Secondary sponsor category [1] 2190 0
University
Name [1] 2190 0
Dept of Surgery, Adelaide University
Address [1] 2190 0
Adelaide, South Australia
Country [1] 2190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4247 0
Royal Adelaide Hospital
Ethics committee address [1] 4247 0
Ethics committee country [1] 4247 0
Australia
Date submitted for ethics approval [1] 4247 0
Approval date [1] 4247 0
07/04/1994
Ethics approval number [1] 4247 0
940402

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27894 0
Prof David Watson
Address 27894 0
Dept Surgery
Flinders University
SA 5042
Country 27894 0
Australia
Phone 27894 0
+61882046086
Fax 27894 0
+61882046130
Email 27894 0
david.watson@flinders.edu.au
Contact person for public queries
Name 10980 0
Professor David Watson
Address 10980 0
Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 10980 0
Australia
Phone 10980 0
+61 8 82046086
Fax 10980 0
+61 8 82046130
Email 10980 0
david.watson@flinders.edu.au
Contact person for scientific queries
Name 1908 0
Professor David Watson
Address 1908 0
Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 1908 0
Australia
Phone 1908 0
+61 8 82046086
Fax 1908 0
+61 8 82046130
Email 1908 0
david.watson@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial was commenced over 20 yrs ago and follow-up has now closed


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.